Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04671251 | Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma | PHASE1 | COMPLETED | 13 | — | — | Dec 15, 2020 | Mar 30, 2022 | Feb 29, 2024 | 7 | United States |
Identify the recommended Phase 2 dose based on safety, pharmacokinetics and pharmacodynamics observed in this Phase 1b study.
| Arm | Type | Description |
|---|---|---|
| AEVI-007 | EXPERIMENTAL | Open-label, dose-escalation, single-arm |
| Name | Type | Description |
|---|---|---|
| AEVI-007 | DRUG | 50 mg of AEVI-007 and will be reconstituted with 1.2 mL of water for injection. |
Inclusion Criteria: 1. Subject has active R/R multiple myeloma. 2. Subject has measurable myeloma based on any of the following: * Serum M-protein \> 0.5 g/dL * Urine M-protein \> 200 mg/24 hours * Serum free light chains \> 10 mg/dL * Measurable plasmacytoma or extramedullary disease ...